Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

This study has been completed.

Sponsor:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00697788

First Posted: June 16, 2008

Last Update Posted: July 17, 2017

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Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

2 Years to 18 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

pediatric patient

>25% total body surface area (tbsa) burn and < 90% tbsa

opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)

midazolam requirement > 0.1 mg/kg/hour

treatment team determined that patient should be started on dexmedetomidine